drugset / Trial / NCT04046549

A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant

NCT04046549

Phase 2 Completed 25 enrolled Amgen
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased, living unrelated or human leukocyte antigen (HLA) non-identical living related donor.

Timeline

Start
2019-10-30
Primary completion
2022-07-18
Completion
2023-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Belatacept Protein / enzyme biologic 5 mg/kg Intravenous
Subject Dazodalibep Protein / enzyme biologic 1500 mg Intravenous
Background Methylprednisolone Other / unclassified 500 mg Intravenous
Background Prednisone Other / unclassified 30 mg Oral
Background Thymoglobulin Protein / enzyme biologic 1.5 mg/kg Intravenous
Background Thymoglobulin Protein / enzyme biologic 3 mg/kg Intravenous

Indications